Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq:
CRVS), a clinical-stage biopharmaceutical company, today provided a
business update and reported financial results for the second
quarter ended June 30, 2024.
“We have seen growing evidence supporting the central role of
ITK in T cell biology and the significant potential of ITK
inhibition as a new mechanism to treat a broad range of immune
diseases and cancers,” said Richard A. Miller, M.D., co-founder,
president and chief executive officer of Corvus. “This includes
early data from our Phase 1 clinical trial of soquelitinib in
atopic dermatitis and our ongoing preclinical work exploring ITK
inhibition in autoimmunity and inflammation. Based on this, we are
increasingly optimistic that our ITK platform has the potential to
improve clinical outcomes for a range of indications as an oral
medication with an attractive tolerability profile. We have
leveraged our experience in T cell lymphomas which has allowed us
to gain a deeper understanding of the role of ITK in T cell biology
that we can now apply to immune diseases. We remain on track to
initiate a Phase 3 registrational trial in PTCL in the third
quarter.”
Business Update and Strategy
Prioritized Program: Soquelitinib (formerly CPI-818,
Corvus’ selective ITK inhibitor)
Soquelitinib for Immune Diseases
- Corvus continues to enroll patients at multiple clinical sites
in its randomized, placebo-controlled Phase 1 clinical trial of
soquelitinib in patients with moderate to severe atopic dermatitis.
The trial is planned to enroll 64 patients that have failed at
least one prior therapy across four different 28-day dosing
regimens of soquelitinib compared to a placebo group. The endpoints
include safety and improvement in Eczema Area and Severity Index.
Patients and physicians will be blinded to treatment assignment.
- Initial results, as of July 31, 2024, from three evaluable
patients in the first cohort of the trial that completed the 28-day
dosing regimen and follow-up visit demonstrated signs of clinical
activity and corresponding changes in serum cytokine levels that
are consistent with soquelitinib’s mechanism of action. These
patients received a dose of 100 mg two-times a day, the lowest dose
level planned for the study.
- Corvus anticipates interim data from the Phase 1 clinical trial
will be presented in the fourth quarter of 2024.
- Recent published data from researchers at Cornell University
demonstrated that ITK controls the fate of inflammatory Th17 cells.
When ITK is inhibited by soquelitinib, the Th17 cells convert or
switch to Treg cells that suppress inflammation. Soquelitinib
treatment in an asthma model of mice with allergic airway
inflammation significantly reduced the percentage of Th17 cells in
the lung resulting in an increase in the ratio of Treg to Th17
cells. These studies confirm our understanding of the role of
specific ITK inhibition in inflammation and are relevant to many
immune diseases.
- Corvus continues to advance its next-generation ITK inhibitor
preclinical product candidates, which were designed to deliver
precise T-cell modulation that is optimized for specific immunology
indications. The next-generation ITK inhibitor candidates are part
of the Company’s ongoing business development efforts to maximize
the potential of the Company’s ITK inhibitor programs in immune
diseases and cancers.
Soquelitinib for T Cell Lymphoma
- Corvus continues to follow patients with relapsed T cell
lymphoma in its Phase 1/1b clinical trial (no longer enrolling new
patients) evaluating single agent therapy with soquelitinib.
Updated interim data as of July 16, 2024:
- A total of 25 patients were enrolled in the Phase 1/1b trial at
the optimum 200 mg two-times a day dose and meet the eligibility
criteria for the planned registrational Phase 3 clinical trial
based on ≥1 and ≤3 prior therapies, including 23 evaluable
patients.
- For the 23 evaluable patients, objective responses (complete
response, CR plus partial response, PR) were seen in nine patients
(39%), including six CRs (26%) and three PRs. Compared to the prior
data reported as of May 3, 2024, one patient with continued tumor
regression achieved a CR that previously had a PR at the first
follow up visit. See waterfall plot below.
- Disease control (CR, PR and stable disease) was seen in 14 of
23 patients (61%). The stable disease group included five patients
who achieved tumor reductions that did not meet the criteria for a
PR.
- Corvus anticipates initiating a registrational Phase 3 clinical
trial of soquelitinib in patients with relapsed PTCL in the third
quarter of 2024. There are currently no FDA fully approved agents
for the treatment of relapsed PTCL and the FDA has granted Orphan
Drug Designation for soquelitinib for the treatment of T cell
lymphoma. Recently, the Company received a Pediatric Waiver from
the FDA indicating that it would not be required to conduct
clinical trials in a pediatric population for this indication.
- As recently announced, soquelitinib has received Fast Track
designation for treatment of adult patients with relapsed or
refractory peripheral T cell lymphoma after at least 2 lines of
systemic therapy.
Waterfall Plot for Patients in the 200 mg Dose Cohort of
the Soquelitinib Phase 1/1b Clinical Trial for Peripheral T Cell
Lymphoma. The plot shows the best percent change in tumor
volume in the 23 evaluable patients (eligible patient population),
as of July 16, 2024, that were measurable by CT scan or by Modified
Severity-Weighted Assessment Tool (mSWAT) for patients with
cutaneous involvement. PTCL-NOS, peripheral T cell lymphoma not
otherwise specified; CTCL, cutaneous T cell lymphoma of either
Sezary or mycosis fungoides type; NKTCL, natural killer cell T cell
lymphoma; ALCL, anaplastic large cell lymphoma; AITL,
angioimmunoblastic T cell lymphoma.
Collaboration with Kidney Cancer Research Consortium:
Ciforadenant (adenosine A2a receptor inhibitor)
- Corvus is collaborating with the Kidney Cancer Research
Consortium in a Phase 1b/2 clinical trial evaluating ciforadenant
as a potential first line therapy for metastatic renal cell cancer
(RCC) in combination with ipilimumab (anti-CTLA-4) and nivolumab
(anti-PD-1). The efficacy endpoint for the trial is deep response
rate, defined as CR plus PRs of greater than 50% tumor volume
reduction. The clinical trial is expected to enroll up to 60
patients and as of May 31, 2024 a total of 32 patients were
enrolled in the trial. The protocol defined, interim pre-specified
statistical threshold for efficacy is a 50% increase above the 32%
deep response rate seen with previous ipilimumab/nivolumab
combination trials in RCC conducted by investigators at the Kidney
Cancer Research Consortium. As of May 31, 2024, the interim
analysis of the clinical trial has met the threshold for efficacy
and therefore enrollment continues.
- In July 2024, a new U.S. patent was issued (United States
Patent No. 12,023,337) by the U.S. Patent and Trademark Office that
covers the use of ciforadenant for the treatment of cancer; foreign
counterparts are pending.
Partner Led Program: Mupadolimab
(anti-CD73)
- Angel Pharmaceuticals, Corvus’ partner in China, is enrolling
patients in an expansion cohort of a Phase 1/1b clinical trial of
mupadolimab in patients with relapsed non-small cell lung cancer
(NSCLC). In this clinical trial, patients will receive mupadolimab
monotherapy.
Financial Results
As of June 30, 2024, Corvus had cash, cash equivalents and
marketable securities of $47.2 million as compared to $27.1
million as of December 31, 2023. During the quarter ended June 30,
2024, the Company completed a registered direct offering in which
it sold shares of common stock, pre-funded warrants and common
warrants, generating $30.3 million in net proceeds.
Corvus expects full year 2024 net cash used in operating
activities to be between approximately $24 million and $27 million,
resulting in a projected cash balance of between approximately $31
million and $34 million at December 31, 2024. Based on its current
plans, Corvus expects its cash to fund operations into the fourth
quarter of 2025.
Research and development expenses for the three months ended
June 30, 2024 totaled $4.1 million compared to $4.0 million for the
same period in 2023. The increase of $0.1 million was primarily due
to higher clinical trial costs associated with the development of
soquelitinib.
The net loss for the three months ended June 30, 2024 was $4.3
million compared to a net loss of $6.5 million for the same period
in 2023. Total stock compensation expense for the three months
ended June 30, 2024 was $0.8 million compared to $0.5 for the same
period in 2023 and the non-cash loss from Corvus’ equity method
investment in Angel Pharmaceuticals was $0.6 million for the three
months ended June 30, 2024 compared to a loss of $1.3 million for
the same period in 2023. In addition, the Company recorded a
non-cash gain of $1.8 million from the change in fair value of its
warrant liability during the three months ended June 30, 2024 due
to the warrants issued in the registered direct offering.
Conference Call DetailsCorvus will host a
conference call and webcast today, Tuesday, August 6, 2024,
at 4:30 p.m. ET (1:30 p.m. PT), during which time
management will provide a business update and discuss the second
quarter 2024 financial results. The conference call can be accessed
by dialing 1- 800-717-1738 (toll-free domestic) or 1- 646-307-1865
(international) or by clicking on this link for instant telephone
access to the event. The live webcast may be accessed via the
investor relations section of the Corvus website. A replay of the
webcast will be available on Corvus’ website for 90 days.
About Corvus PharmaceuticalsCorvus
Pharmaceuticals is a clinical-stage biopharmaceutical company
pioneering the development of ITK inhibition as a new approach to
immunotherapy for a broad range of cancer and immune diseases. The
Company’s lead product candidate is soquelitinib, an
investigational, oral, small molecule drug that selectively
inhibits ITK. Its other clinical-stage candidates are being
developed for a variety of cancer indications. For more
information, visit www.corvuspharma.com.
About SoquelitinibSoquelitinib (formerly
CPI-818) is an investigational small molecule drug given orally
designed to selectively inhibit ITK (interleukin-2-inducible T cell
kinase), an enzyme that is expressed predominantly in T cells and
plays a role in T cell and natural killer (NK) cell immune
function. Based on interim results from a Phase 1/1b clinical trial
in patients with refractory T cell lymphomas, which demonstrated
tumor responses in very advanced, refractory, difficult to treat T
cell malignancies, the Company plans to initiate a registrational
Phase 3 clinical trial of soquelitinib in patients with relapsed
PTCL. Soquelitinib also is now being investigated in a randomized
placebo controlled phase 1 clinical trial in patients with atopic
dermatitis. The immunologic effects of soquelitinib lead to what is
known as Th1 skewing and inhibition of Th2 and Th17 cells. Research
on soquelitinib’s mechanism of action suggests that it has the
potential to control differentiation of normal T helper cells and
enhance immune responses to tumors by augmenting the generation of
cytotoxic killer T cells and the production of cytokines that
inhibit cancer cell survival. Soquelitinib has also been shown to
prevent T cell exhaustion, a major limitation of current
immunotherapy and CAR-T therapies. Soquelitinib has been shown to
affect T cell differentiation and induce the generation of Th1
helper cells while blocking the development of both Th2 and Th17
cells and production of their secreted cytokines. Th1 T cells are
required for immunity to tumors, viral infections and other
infectious diseases. Th2 and Th17 helper T cells are involved in
the pathogenesis of many autoimmune and allergic diseases. The
Company believes the inhibition of specific molecular targets in T
cells may be of therapeutic benefit for patients with cancers,
including solid tumors, and in patients with autoimmune and
allergic diseases.
About Peripheral T Cell LymphomaPeripheral T
cell lymphoma is a heterogeneous group of malignancies accounting
for about 10% of non-Hodgkin’s lymphomas (NHL) in Western
populations, reaching 20% to 25% of NHL in some parts of Asia and
South America. The most common subtypes are PTCL-not otherwise
specified (PTCL-NOS) and T follicular helper cell lymphoma. First
line treatment for these diseases is typically combination
chemotherapy, however, approximately 75% of patients either do not
respond or relapse within the first two years. Patients in relapse
are treated with various chemotherapy agents but have poor overall
outcomes with median progression-free survival in the three to four
month range and overall median survival of six to 12 months. There
are no approved drugs in relapsed PTCL based on randomized
trials.
PTCL is a disease of mature helper T cells that express ITK,
often containing numerous genetic mutations and frequently
associated with viral infection. Most often the malignant cells of
PTCL express a Th2 phenotype.
About Atopic DermatitisAtopic dermatitis, also
called eczema, is a chronic disease that can cause inflammation,
redness, scaly patches, blisters and irritation of the skin. It
affects up to 20% of children and up to 10% of adults, and
treatments include topical therapies, oral therapies and systemic
injectable biologic therapies. It is frequently associated with
other allergic disorders such as food allergies and asthma. Atopic
dermatitis, like asthma and allergy, involves the participation of
Th2 lymphocytes which secrete cytokines that result in
inflammation. Soquelitinib has been shown in preclinical studies to
inhibit cytokine production from Th2 lymphocytes.
About CiforadenantCiforadenant (CPI-444) is an
investigational small molecule, oral, checkpoint inhibitor designed
to disable a tumor’s ability to subvert attack by the immune system
by blocking the binding of adenosine to immune cells present in the
tumor microenvironment. Adenosine, a metabolite of ATP (adenosine
tri-phosphate), is produced within the tumor microenvironment where
it may bind to the adenosine A2a receptor present on immune cells
and block their activity. Ciforadenant has been shown to block the
immunosuppressive effects of myeloid cells present in tumors and
preclinical studies published in 2018 demonstrated synergy with
combinations of anti PD1 and anti-CTLA4 antibodies.
About MupadolimabMupadolimab (CPI-006) is an
investigational, potent humanized monoclonal antibody that is
designed to react with a specific site on CD73. In preclinical
studies, it has demonstrated immunomodulatory activity resulting in
activation of lymphocytes, induction of antibody production from B
cells and effects on lymphocyte trafficking. While there are other
anti-CD73 antibodies and small molecules in development for
treatment of cancer, such agents react with a different region of
CD73. Mupadolimab is designed to react with a region of the
molecule that acts to stimulate B cells and block production of
immunosuppressive adenosine. Mupadolimab is being studied in
combination with pembrolizumab in a Phase 1b/2 clinical trial in
patients with advanced head and neck cancers and in patients with
NSCLC that have failed chemotherapy and anti-PD(L)1 therapy. It is
postulated that the activation of B cells will enhance immunity
within the tumors of these patients, leading to improved clinical
outcomes.
About Angel PharmaceuticalsAngel
Pharmaceuticals is a privately held biopharmaceutical company
developing a pipeline of precisely targeted investigational
medicines for cancer, autoimmune, infectious and other serious
diseases in China. Angel Pharmaceuticals was launched through a
collaboration with U.S.-based Corvus and investments from investors
in China. Angel Pharmaceuticals licensed the rights to develop and
commercialize Corvus’ three clinical-stage candidates –
soquelitinib, ciforadenant and mupadolimab – in greater China and
obtained global rights to Corvus’ BTK inhibitor preclinical
programs. Under the collaboration, Corvus currently has a 49.7%
equity stake in Angel Pharmaceuticals excluding 7% of Angel’s
equity reserved for issuance under the Angel ESOP, and Corvus has
designated three individuals on Angel’s five-person Board of
Directors. For more information, visit www.angelpharma.com.
Forward-Looking StatementsThis press release
contains forward-looking statements, including statements related
to the potential safety and efficacy of the Company’s product
candidates including soquelitinib, ciforadenant and mupadolimab;
the potential use of soquelitinib to treat a variety of
hematological cancers and autoimmune diseases; the Company’s
ability and its partners’ ability, as well as the timing thereof,
to develop and advance product candidates into and successfully
complete preclinical studies and clinical trials, including the
Company’s Phase 1 clinical trial for atopic dermatitis with
soquelitinib; the timing of and the Company’s ability to launch
clinical trials, including the soquelitinib registrational Phase 3
clinical trial for PTCL; the design of clinical trials, including
the timeline for initiation, target or expected number of patients
to be enrolled, expected number of sites and certain other product
development milestones, including in regards to the Phase 1
clinical trial for atopic dermatitis with soquelitinib; the
availability and timing of clinical and preclinical data
announcements and clinical readouts, including early data from the
Phase 1 clinical trial for atopic dermatitis with soquelitinib and
preclinical data supporting the broad potential of ITK inhibition
in immune and inflammatory disease; the estimated amount of net
cash used in operating activities for 2024 and its ability to fund
operations into the fourth quarter of 2025. All statements other
than statements of historical fact contained in this press release
are forward-looking statements. These statements often include
words such as “believe,” “expect,” “anticipate,” “intend,” “plan,”
“estimate,” “seek,” “will,” “may” or similar expressions.
Forward-looking statements are subject to a number of risks and
uncertainties, many of which involve factors or circumstances that
are beyond the Company’s control. The Company’s actual results
could differ materially from those stated or implied in
forward-looking statements due to a number of factors, including
but not limited to, risks detailed in the Company’s Quarterly
Report on Form 10-Q for the three months ended June 30, 2024, filed
with the Securities and Exchange Commission on or about the date
hereof, as well as other documents that may be filed by the Company
from time to time with the Securities and Exchange Commission. In
particular, the following factors, among others, could cause
results to differ materially from those expressed or implied by
such forward-looking statements: the Company’s ability to
demonstrate sufficient evidence of efficacy and safety in its
clinical trials of soquelitinib and its other product candidates;
the accuracy of the Company’s estimates relating to its ability to
initiate and/or complete preclinical studies and clinical trials
and release data from such studies and clinical trials; the results
of preclinical studies and interim data from clinical trials not
being predictive of future results; the Company’s ability to enroll
sufficient numbers of patients in its clinical trials; the
unpredictability of the regulatory process; regulatory developments
in the United States, and other foreign countries; the costs of
clinical trials may exceed expectations; the Company’s ability to
accurately estimate the amount of net cash used in operating
activities for 2024 and cash on hand providing funding into the
fourth quarter of 2025 and the Company’s ability to raise
additional capital. Although the Company believes that the
expectations reflected in the forward-looking statements are
reasonable, it cannot guarantee that the events and circumstances
reflected in the forward-looking statements will be achieved or
occur, and the timing of events and circumstances and actual
results could differ materially from those projected in the
forward-looking statements. Accordingly, you should not place undue
reliance on these forward-looking statements. All such statements
speak only as of the date made, and the Company undertakes no
obligation to update or revise publicly any forward-looking
statements, whether as a result of new information, future events
or otherwise. The Company’s results for the quarter ended June 30,
2024 are not necessarily indicative of its operating results for
any future periods.
CORVUS
PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS (in thousands, except share and
per share data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
|
(unaudited) |
|
(unaudited) |
Operating
expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
|
|
$ |
4,114 |
|
|
$ |
3,968 |
|
|
$ |
8,189 |
|
|
$ |
8,562 |
|
General and administrative |
|
|
|
1,821 |
|
|
|
1,654 |
|
|
|
3,999 |
|
|
|
3,634 |
|
Total
operating expenses |
|
|
|
5,935 |
|
|
|
5,622 |
|
|
|
12,188 |
|
|
|
12,196 |
|
Loss from
operations |
|
|
|
(5,935 |
) |
|
|
(5,622 |
) |
|
|
(12,188 |
) |
|
|
(12,196 |
) |
Interest
income and other expense, net |
|
|
|
434 |
|
|
|
403 |
|
|
|
750 |
|
|
|
779 |
|
Change in
fair value of warrant liability |
|
|
|
1,816 |
|
|
|
— |
|
|
|
1,816 |
|
|
|
— |
|
Sublease
income - related party |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
56 |
|
Loss from
equity method investment |
|
|
|
(577 |
) |
|
|
(1,284 |
) |
|
|
(341 |
) |
|
|
(3,015 |
) |
Net
loss |
|
|
$ |
(4,262 |
) |
|
$ |
(6,503 |
) |
|
$ |
(9,963 |
) |
|
$ |
(14,376 |
) |
Net loss per
share, basic and diluted |
|
|
$ |
(0.07 |
) |
|
$ |
(0.14 |
) |
|
$ |
(0.18 |
) |
|
$ |
(0.31 |
) |
Shares used
to compute net loss per share, basic and diluted |
|
|
|
59,710,265 |
|
|
|
47,497,414 |
|
|
|
54,374,423 |
|
|
|
47,029,396 |
|
CORVUS
PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED
BALANCE SHEETS (in thousands) |
|
|
|
|
|
|
|
June
30, |
|
December
31, |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
(unaudited) |
|
|
Assets |
|
|
|
|
Cash, cash equivalents and marketable securities |
|
$ |
47,246 |
|
|
$ |
27,149 |
|
Operating lease right-of-use asset |
|
|
578 |
|
|
|
1,149 |
|
Other assets |
|
|
1,333 |
|
|
|
1,132 |
|
Investment in Angel Pharmaceuticals |
|
|
15,404 |
|
|
|
16,123 |
|
Total
assets |
|
$ |
64,561 |
|
|
$ |
45,553 |
|
Liabilities
and stockholders' equity |
|
|
|
|
Accounts payable and accrued liabilities and other liabilities |
|
$ |
5,517 |
|
|
$ |
5,495 |
|
Operating lease liability |
|
|
700 |
|
|
|
1,374 |
|
Warrant liability |
|
|
7,118 |
|
|
|
— |
|
Stockholders' equity |
|
|
51,226 |
|
|
|
38,684 |
|
Total
liabilities and stockholders' equity |
|
$ |
64,561 |
|
|
$ |
45,553 |
|
|
|
|
|
|
INVESTOR CONTACT:Leiv LeaChief Financial
OfficerCorvus Pharmaceuticals,
Inc.+1-650-900-4522llea@corvuspharma.com
MEDIA CONTACT:Sheryl SeapyReal
Chemistry+1-949-903-4750sseapy@realchemistry.com
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/a451d560-a41c-4487-99ca-cd7de11e4274
Corvus Pharmaceuticals (NASDAQ:CRVS)
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Corvus Pharmaceuticals (NASDAQ:CRVS)
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